Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
24/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Nicole Ezendam

ORCID ID

Contact details

Erasmus Medical Centre
Department of Public Health
Room AE-139
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 408 9253
n.ezendam@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw: 3138

Study information

Scientific title

Acronym

Study hypothesis

1. The intervention group will have a lower Body Mass Index (BMI)/waist circumference, compared to the control group at follow-up
2. The intervention group will have more favourable outcomes on the targeted behaviours, compared to the control group at follow-up
3. The intervention group will be more aware of their risk behaviours and have more positive attitudes, perceived behavioural control and intentions to change for their risk behaviours, compared to the control group at follow-up
4. Availability and accessibility of foods and physical activity opportunities moderates the intervention effects

In addition to testing these main hypotheses, secondary analysis will be performed to answer other relevant research questions.

Ethics approval

Approval received from the local medical ethics committee (Medisch Ethische Toetsings Commissie Erasmus MC [METC]) on the 7th June 2006 (ref: MEC-2005-364).

Study design

Randomised, controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

No condition, healthy person

Intervention

Intervention group:
The pupils in the intervention schools will use a computer-tailored intervention on weight gain related behaviours (physical activity, sedentary behaviour, snack, fruit and vegetable, fibre and soft-drink consumption) during their first year of secondary school. The intervention will be used during school hours as part of the education program. The intervention will be used for an average of two hours (preferably divided by eight times 15 minutes) within ten subsequent weeks.

Control group:
The control group will receive regular school lessons. After two years the intervention will be available for the control group as well.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. BMI calculated from measured height and weight, at baseline and two year follow-up
2. Waist circumference measured between hip bone and lowest rib, at baseline and two year follow-up

Secondary outcome measures

1. Physical activity measured with self-report questionnaires plus pedometer counts (for part of the participants) at baseline, three months and two year follow-up
2. Physical condition measured with a shuttle-run-test at baseline and two year follow-up
3. Various dietary sub-behaviours, i.e. fruit and vegetable consumption, soft-drink consumption, snack consumption and fibre consumption measured with self-report questionnaires at baseline, three months and two year follow-up
4. Amount of television viewing/time spend with the computer measured with self-report questionnaires at baseline, three month and two year follow-up
5. Awareness of personal bodyweight status, overweight-related risk perceptions, weight maintenance attitudes, perceived behavioural control, and motivation to engage in weight maintenance behaviours, measured with self-report questionnaires at baseline, three months and two year follow-up
6. Determinants of change for the separate dietary, physical activity and sedentary behaviours, as measured by self-report questionnaires, distributed at baseline, three months and two year follow-up

Overall trial start date

01/06/2006

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Secondary schools (locations) in the municipal health organisation regions: Rotterdam and surrounding areas and Nieuwe Waterweg Noord.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

1200

Participant exclusion criteria

1. Schools (locations) where pupils have very low reading capacity (i.e. pupils that are not able to fill in a questionnaire)
2. Schools (locations) that offer special sports education (i.e. special sports schools)
3. Schools (locations) where the pupils could not be followed-up to the third year, i.e. schools that only provide education for the first two years of secondary education (onderbouw) and where the pupils could not be tracked to other

Recruitment start date

01/06/2006

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/17997834
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22064878
3. 2012 evaluation in http://www.ncbi.nlm.nih.gov/pubmed/22692481

Publication citations

  1. Study protocol

    Ezendam NP, Oenema A, van de Looij-Jansen PM, Brug J, Design and evaluation protocol of "FATaintPHAT", a computer-tailored intervention to prevent excessive weight gain in adolescents., BMC Public Health, 2007, 7, 324, doi: 10.1186/1471-2458-7-324.

  2. Results

    Ezendam NP, Brug J, Oenema A, Evaluation of the Web-based computer-tailored FATaintPHAT intervention to promote energy balance among adolescents: results from a school cluster randomized trial., Arch Pediatr Adolesc Med, 2012, 166, 3, 248-255, doi: 10.1001/archpediatrics.2011.204.

  3. Evaluation

    Ezendam NP, Noordegraaf VS, Kroeze W, Brug J, Oenema A, Process evaluation of FATaintPHAT, a computer-tailored intervention to prevent excessive weight gain among Dutch adolescents., Health Promot Int, 2013, 28, 1, 26-35, doi: 10.1093/heapro/das021.

Additional files

Editorial Notes